scholarly journals Impact Evaluation of Changes in the Manufacturing Line of Cyproterone Acetate through Analysis of Comparative Dissolution Profile

2014 ◽  
Vol 1 (2) ◽  
pp. 107-114
Author(s):  
Terezinha de Jesus Andreoli Pinto ◽  
Rogério Takao Okamoto ◽  
Wesley Anderson de Oliveira ◽  
Daniela Dal Molim Ghisleni
Keyword(s):  
Impact Evaluation ◽  
Cyproterone Acetate ◽  
Dissolution Profile ◽  
Manufacturing Line ◽  
Comparative Dissolution

scholarly journals Uji Disolusi Terbanding Tablet Ofloxacin Berlogo dan Generik Bermerek Terhadap Inovator Dalam Media Dapar HCl pH 4,5

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Winsa Wira Wijaya ◽  
Prima Happy Ratnapuri ◽  
Mia Fitriana
Keyword(s):  
Acetate Buffer ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Branded Drug ◽  
Similarity Factor ◽  
Difference Factor ◽  
Zwitter Ion ◽  
Dissolution Efficiency ◽  
Comparative Dissolution

ABSTRAK Uji disolusi terbanding merupakan pengujian yang dapat digunakan untuk memastikan ekivalensi dan sifat-sifat produk obat. Uji disolusi terbanding dilakukan dalam media disolusi dengan pH yang disesuaikan dengan kondisi in vivo yaitu pada pH 1,2; 4,5; dan 6,8. Obat generik dan generik bermerek yang wajib uji ekivalensi salah satunya yaitu ofloxacin. Ofloxacin merupakan suatu obat yang memiliki sifat kationik, anionik, dan zwitter ion. Penelitian ini bertujuan untuk menentukan ekivalensi profil disolusi terbanding yang dianalisis dengan parameter f1, f2, dan DE70 antara ofloxacin generik berlogo dan generik bermerek terhadap inovator dalam media dapar asetat pH 4,5. Uji disolusi dilakukan sesuai USP 32-NF 27 yaitu menggunakan alat uji tipe 2 pada suhu 37 ± 0,50C dengan kecepatan putar 50 rpm. Analisis hasil yang digunakan untuk menentukan ekivalensi profil disolusi yaitu difference factor (f1), similarity factor (f2), dan dissolution efficiency (DE70). Hasil penelitian ini memberikan kesimpulan bahwa sampel yang memiliki ekivalensi profil disolusi terbanding yang dianalisis dengan parameter f1, f2, dan DE70 terhadap produk inovator dalam media dapar asetat pH 4,5 yaitu sampel A (generik bermerek) dan sampel B (generik berlogo). Kata kunci : ofloxacin, disolusi terbanding, difference factor (f1), similarity factor (f2), dan dissolution efficiency (DE70). ABSTRACT Comparative dissolution is a test that can be used to ensure equivalence and properties of medicinal products. Comparative dissolution test has done in a dissolution medium with pH adjusted to in vivo conditions at pH 1,2; 4,5; and 6,8. One of generic and generic branded drug that need equivalence test is ofloxacin. Ofloxacin is a drug which are cationic, anionic, and zwitter ion. The aim of this study was to determine equivalence comporative of dissolution profiles, then analyzed with f1, f2, and DE70 parameters between generic and generic branded to innovators ofloxacin in media acetate buffer pH 4,5. Dissolution test was accordance to USP 32-NF 27 that used equipment test type 2 at temperature 37 ± 0,50 C with rotary speed 50 rpm. The analysis results were used to determine equivalence dissolution profile e.g. difference factor (f1), similarity factor (f2), and dissolution efficiency (DE70). The results this study showed that samples had equivalence comporative of dissolution profiles which were analyzed with f1, f2, and DE70 parameters to innovator product in media acetate buffer pH 4,5 was sample code A (generic branded) and sample code B (generic). Keywords: ofloxacin, comparative dissolution, difference factor (f1), similarity factor (f2), and dissolution efficiency (DE70).

scholarly journals Alternative Methods for Dissolution Profile Comparison in the Dissolution Test

2021 ◽  
Vol 10 (4) ◽  
pp. 197-207
Author(s):  
D. P. Romodanovsky ◽  
D. V. Goryachev
Keyword(s):  
Active Substance ◽  
Dissolution Kinetics ◽  
Alternative Methods ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Similarity Factor ◽  
Model Independent ◽  
Kinetics Of ◽  
Comparative Dissolution

Introduction. The article discusses the problem of assessing the similarity of the dissolution profiles of two batches of the nebivolol. The use of a generally accepted similarity factor for assessing equivalence is unacceptable in some cases, for example, for drugs with a high variability in the values of the release of the active substance from the formulation. At the same time, at present, there are no generally accepted approaches to comparing the profiles of the dissolution kinetics of drugs, with the exception of the method for assessing the comparability of profiles based on the mathematical calculation of the similarity factor f2, which has certain criteria that limit its application.Aim. To demonstrate alternative methods for assessing the similarity between the dissolution profiles of two drugs using a practical example.Materials and methods. The results of the comparative dissolution test of two series of nebivolol at a dosage of 5 mg. Five model-independent methods for assessing the equivalence of drug dissolution were used. Statistical data processing was performed using Microsoft Excel software.Results and discussion. The paper presents a practical example of using five alternative model-independent methods for assessing the equivalence of the dissolution profile. An example is used to illustrate the proposed equivalence limits and statistical methodology. Also, various approaches to determining the boundaries of equivalence have been proposed to assess the similarity of the dissolution profiles of an active substance.Conclusion. According to the results of the comparative dissolution test of two batches of nebivolol, it was shown that the use of the similarity factor as a criterion for assessing dissolution profiles led to a false positive result. In such cases, the possibility of using alternative methods for assessing the equivalence of dissolution profiles described in the article, or other methods presented in the scientific literature, should be considered, with a justification of their acceptability in each specific case.

Impact Evaluation

2019 ◽  
Author(s):  
Markus Frölich ◽  
Stefan Sperlich
Keyword(s):  
Impact Evaluation

Effects of Cyproterone Acetate on Body Weight and Food Intake

1973 ◽  
Author(s):  
William W. Beatty ◽  
Thomas R. Vilberg ◽  
Paul B. Revland
Keyword(s):  
Body Weight ◽  
Food Intake ◽  
Cyproterone Acetate

The Impact Evaluation of the Maryland Break the Cycle Initiative

2003 ◽  
Author(s):  
Adele Harrell ◽  
John Roman ◽  
Avinash Bhati ◽  
Barbara Parthasarathy
Keyword(s):  
Impact Evaluation ◽  
The Impact

DAMPAK DAN IMPLEMENTASI BANTUAN PEMERINTAH TERHADAP PEMBERDAYAAN MASYARAKAT KABUPATEN BANGGAI

2019 ◽  
Vol 5 (1) ◽  
pp. 77
Author(s):  
Andi Hartati
Keyword(s):  
Impact Evaluation ◽  
Cluster Sampling ◽  
One Stage

Tujuan penelitian ini adalah untuk menganalisis dampak dan implementasi bantuan pemerintah daerah terhadap pemberdayaan masyarakat Kabupaten Banggai. Penentuan daerah sampel dilakukan Teknik pengambilan sampel yang dilakukan menggunakan Metode One-Stage Cluster Sampling yang merupakan teknik memilih sebuah sampel dari kelompok-kelompok unit yang kecil atau membagi populasi menjadi kelompok atau kluster. Beberapa kluster kemudian dipilih sebagai wakil dari populasi yaitu Kecamatan Luwuk Timur, Kecamatan Luwuk Utara dan Kecamatan Luwuk dengan mempertimbangkan jumlah dan jenis bantuan pemerintah yang diterima. Kemudian seluruh elemen dalam kluster terpilih dijadikan sebagai sampel penelitian. Metode   analisis data dengan menggunakan metode deskriptif untuk menjelaskan gambaran umum mengenai Dampak Dan Implementasi Bantuan Pemerintah Terhadap Pemberdayaan Masyarakat Kabupaten Banggai dengan menggunakan metode ImportancePerformance Analysis (IPA). Pengukuran faktor dilakukan membandingkan antara harapan dan kinerja pelaksanaan bantuan pemerintah terhadap pemberdayaan masyarakat Kabupaten Banggai. Metode ini dilakukan dengan pendekatan evaluasi dampak (impact evaluation). Hasil penelitian menunjukkan bahwa implementasi bantuan pemerintah terhadap pemberdayaan masyarakat Kabupaten Banggai diperoleh hasil bahwa bantuan pemerintah yang diberikan kepada masyarakat 99 persen tepat jumlah, 99 persen guna namun 18, 87 persen tidak tepat sasaran, 25, 31 persen tidak tepat waktu. Berdasarkan hasil perhitungan SPSS 17 nilai Sig (2-tailed) adalah sebesar 0,000 < 0,05 bahwa terdapat perbedaan yang signifikan antara pendapatan perbulan sebelum menerima bantuan pemerintah dengan pendapatan perbulan setelah menerima bantuan pemerintah. Dari hasil perhitungan uji t dapat dilihat bahwa harga t = |20,586| dengan tingkat signifikansi 0,00. Harga t pada tabel alpha 0,05 (df 301) adalah 1,967Dengan demikian t hitung 20,586 > t tabel 1,967 dapat ditarik kesimpulan bahwabantuan pemerintah berdampak pada pendapatan masyarakat.

The Impact of the Public Expenditure Cuts Policy on the Labor Market in Vietnam

2012 ◽  
pp. 22-46
Author(s):  
Huong Nguyen Thi Lan ◽  
Toan Pham Ngoc
Keyword(s):  
Labor Market ◽  
Computable General Equilibrium ◽  
Impact Evaluation ◽  
Public Expenditure ◽  
Computable General Equilibrium Model ◽  
Living Standard ◽  
Input Output ◽  
Policy Makers ◽  
The Public ◽  
The Impact

The purpose of this study is to evaluate the impact of public expenditure cuts on employment and income to support policies for the development of the labor mar- ket. Impact evaluation is of interest for policy makers as well as researchers. This paper presents a method – that is based on a Computable General Equilibrium model – to analyse the impact of the public expenditure cuts policy on employment and income in industries and occupations in Vietnam using macro data, the Input output table, 2006, 2008 and the 2010 Vietnam Household Living Standard Survey.

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